在炎症性肠病的随机对照试验中定义粘膜愈合:系统性审查和未来的前景
Tommaso Lorenzo Parigi1,2, Virginia Solitano1,3, Alessandro Armuzzi4,5
1Division of Immunology, Transplantation and Infectious Disease, Università Vita-Salute San Raffaele, Milan, Italy.
在炎症性肠病 (IBD) 中缺少粘膜愈合 (MH) 的标准定义. 定义正在演变,特别是在性结肠炎中,趋向于多模式评估以更好地评估治疗.
科学领域:
- 胃肠病学和肝病学 胃肠学和肝病学
- 临床试验方法论 临床试验方法论
- 炎症性肠道疾病研究研究
背景情况:
- 粘膜愈合 (MH) 是炎症性肠病 (IBD) 的一个关键治疗目标.
- 现有的MH定义在不同研究中存在很大差异.
- 这种变异性使临床试验结果的解释和比较变得复杂.
研究的目的:
- 系统地审查和识别随机对照试验 (RCT) 中使用的MH定义.
- 在性结肠炎 (UC) 和克罗恩病 (CD) 的RCT中比较MH的定义.
- 在IBD研究中随着时间的推移跟踪MH定义的演变.
主要方法:
- 在MEDLINE,EMBASE和Cochrane图书馆进行了全面的文献搜索.
- 包括UC和CD中先进疗法的2期和3期RCT,发表至2023年12月.
- 分析了在选定的RCT中作为终点报告的MH定义.
主要成果:
- 包括144个RCT (72个UC,72个CD),发表于1997年至2023年之间.
- 在UC中,64%的RCT报告了MH,使用了12个不同的定义,越来越多地结合了内镜和组织学评估.
- 在CD中,只有12%的RCT定义了MH,仅限于对组织学的使用;很少评估过神经愈合.
结论:
- 在IBD中缺乏对MH的标准化定义.
- 定义已经演变,特别是在UC中,结合了组织学.
- 需要对MH定义进行标准化,预测更严格的多式联运终点.
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